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Md. Code Ann., Health-Gen. § 21-2C-01

Redline — January 1, 2020 → current.View current text →
Current — January 1, 2026
As of January 1, 2020
(a) In this subtitle the following words have the meanings indicated.
(a) In this subtitle the following words have the meanings indicated.
(b) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.
(b) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.
(c) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).
(c) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).
(d) “Board” means the Prescription Drug Affordability Board.
(d) “Board” means the Prescription Drug Affordability Board.
(e) (1) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).
(e) (1) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).
(2) “Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.
(2) “Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.
(f) “Current shortage” means a drug:
(1) Listed as current on the federal Food and Drug Administration’s Drug Shortage Database; or
(2) Otherwise determined by the Board to be in short supply in the State.
(f) “Generic drug” means: (1) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j); (2) An authorized generic as defined by 42 C.F.R. § 447.502; or (3) A drug that entered the market before 1962 that was not originally marketed under a new drug application.
(g) “Generic drug” means: (1) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j); (2) An authorized generic as defined by 42 C.F.R. § 447.502; or (3) A drug that entered the market before 1962 that was not originally marketed under a new drug application.
(g) “Manufacturer” means an entity that: (1) (i) Engages in the manufacture of a prescription drug product; or (ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and (2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.
(h) “Manufacturer” means an entity that: (1) (i) Engages in the manufacture of a prescription drug product; or (ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and (2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.
(h) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
(i) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
(i) “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.
(j) “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.

Official source: Maryland General Assembly. Reproduced from public-domain Maryland statutes; confirm against the official source for the current text. Not legal advice.